FDA 510(k) clearances — page 388
clearances on record, most recent first.
Clearances — page 388
38,701–38,800 of 176,542- K132788 — MYSPINE PEDICLE SCREW PLACEMENT GUIDES
- K132838 — NUTRA LIGHT BLUE
- K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR
- K133173 — RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
- K133405 — MINNIE
- K133694 — SHERPA PAK TRANSPORTER
- K140384 — FMWAND HANDPIECE SE
- K140548 — CORCAM HEART MONITOR
- K140630 — WALLFLEX BILIARY RX STENT SYSTEM
- K140729 — APLIO ARTIDA, V3.2
- K141067 — VIVID T8/VIVID T8 PRO
- K141131 — TIGHTRAIL MINI
- K123876 — SYNERGY
- K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
- K131892 — EV1000 CLINICAL PLATFORM
- K132681 — SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
- K133121 — CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
- K133269 — ZOLL X SERIES
- K133351 — NEXUS NIS-6P LUER ACTIVATED DEVICE
- K133790 — IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
- K140027 — ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
- K140192 — CARPENTIER BI-CAVAL FEMORAL CANNULA
- K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2
- K140412 — ANS1 SOFTWARE
- K140426 — ANTHRACIS REAL-TIME PCR ASSAY
- K140454 — NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
- K140455 — CAPTIA MEASLES IGM
- K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
- K140529 — EVEREST SPINAL SYSTEM
- K140792 — SALVATION 3DI PLATING SYSTEM
- K141220 — APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
- K131609 — DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
- K132470 — SOLUM IV BONE VOID FILLER
- K132802 — MOTEX POWDERED NITRILE SURGICAL GLOVES
- K132937 — HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
- K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
- K133482 — SILC FIXATION SYSTEM
- K133598 — CARDIOHELP SYSTEM
- K133738 — NOVOFINE PLUS 32G 4 MM
- K134043 — NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
- K140074 — HYGEDENT ALGINATE IMPRESSION MATERIAL
- K140094 — SPRINGTMS TOTAL MIGRAINE SYSTEM
- K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
- K140169 — VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
- K140340 — SKINTACT
- K140533 — GALAFLEX MESH
- K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM
- K132291 — NAMSA CHEMICAL PROCESS
- K132377 — OSTEOSPAN MORPHEUS
- K133082 — OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
- K140095 — PRIME ZOOM STRETCHER
- K140165 — MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
- K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K140447 — BD VIPER LT SYSTEM
- K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
- K140483 — ASAP OTC WOUND DRESSING GEL
- K140576 — Y WIRE 2
- K140835 — GENERAL AND PLASTIC SURGERY
- K140925 — ACUMED SUTURE ANCHOR SYSTEM
- K140948 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K141023 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- K132108 — MAXIO
- K132703 — THUNDERBEAT
- K133014 — DMS 300-2W HOLTER ECG RECORDER
- K133793 — PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
- K133853 — VIEWFLEX XTRA ICE CATHETER
- K140526 — NXSTAGE SYSTEM ONE
- K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
- K141043 — CS2 MULTI-HOLE ACETABULAR SHELL
- K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
- K132037 — VITAL SIGNS MONITOR
- K132694 — NUVASIVE NVM5 SYSTEM
- K133257 — BIOPSY PIPETTES
- K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
- K133988 — TEMPUS PRO EXTENDED FEATURES
- K140054 — RESCAN
- K140287 — AXERA RX ACCESS SYSTEM
- K140631 — LUMENA FH HAIR REMOVAL SYSTEM
- K140693 — VSCAN WITH DUAL PROBE
- K140942 — KLASSIC KNEE TIBIAL STEM EXTENSION
- K141041 — APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K131941 — FETAL MONITORS
- K132225 — EXTRICARE
- K133304 — RXG DISTRACTION SYSTEM
- K133662 — SMITH & NEPHEW CANNULATED CAPTURED SCREW
- K133664 — ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
- K133752 — SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
- K133763 — SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
- K134001 — FIREFLY
- K140133 — INFUSET FLOW CONTROL EXTENSION SET
- K140187 — RAY STATION
- K140235 — XGEO GR40CW
- K140329 — RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
- K140571 — NXSTAGE PUREFLOW SL
- K140741 — SALVATION BEAMS AND BOLTS SYSTEM
- K140952 — CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
- K141093 — 6VT-D ULTRASOUND TRANSDUCER
- K131069 — QUICKSCREEN AMPHETINE 500 TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.